Kornimate/medical-research-clean huggingface dataset:
effect of enzalutamide dose reduction on fatigue, cognition, and drug trough levels in patients with prostate cancer

Conditions: Prostate Cancer

Summary: the primary purpose of this trial is to determine whether dose reduction of enzalutamide in patients with grade 3 fatigue and/or cognition change will lead to an improvement in symptoms while maintaining active drug levels. patients within 3 months of starting enzalutamide will be assessed by their oncologist as being potentially eligible for dose reduction due to the onset of moderate to severe fatigue and/or cognition change, which is assessed as being due to enzalutamide


Eligibility criteria:
inclusion criteria: 1. patients with prostate cancer who have commenced enzalutamide within 3 months 2. patient must have concomitant lhrh agonist or antagonist (no single agent enzalutamide) 3. receiving enzalutamide before or after docetaxel 4. patients may have hormone-sensitive or castrate resistant disease 5. patients may have metastatic (m1) or non-metastatic (m0) disease 6. onset of grade 3 or more cognition change and/or fatigue after commencement of enzalutamide considered to be due to enzalutamide exclusion criteria: 1. clinical dementia 2. concomitant use of drugs known to impair cognition such as benzodiazepines or antihistamines. 3. concomitant use of strong cyp3a4 and/ or cyp2c8 inducers or inhibitors. 4. patient expected to have a change in opioid dose during the study period or have had a change 4 weeks before study entry. 5. diagnosed with sleep apnoea 6. brain metastases, prior seizures, drugs that significantly reduce seizure threshold. 7. active infection or other intercurrent illness that may contribute to fatigue or cognition change within 4 weeks of study entry.
survey of non-variceal upper gastro intestinal bleeding in vietnamese patients

Conditions: Re-bleeding in NVUGIB

Summary: the main aim of the study is to describes the outcomes of patients with upper gastrointestinal bleed (ugib) in a real-life setting. additionally analyse assessed predictors of outcome, including the impact of hemostatic endoscopic and pharmacologic therapies.

msd

Eligibility criteria:
inclusion criteria: * adult patients (\>=18yrs) admitted to the hospital, or inpatients admitted for another reason, presenting with overt non-variceal upper gi bleed manifesting as hematemesis/coffee ground vomiting, melena, hematochezia... * evidence that an upper gi endoscopy was performed exclusion criteria: * gi bleeding not from nvugib

Keywords: re-bleeding, nvugib
safe nerve sparing guided by micro-ultrasound (mus)

Conditions: Prostate Cancer; Erectile Dysfunction

Summary: robotic-assisted radical prostatectomy (ralp) has become the standard of care in the management of localized prostate cancer. however, post-prostatectomy erectile dysfunction (ed) and urinary incontinence still pose a challenge that adversely affects the patient's quality of life. hydrodissection (hd) was introduced in 1987 in the medical field and it was tested for the first time during a retropubic radical prostatectomy back in 2005. since then, research has indicated an improvement in erectile function results, presumably because of a less traumatic neural dissection and a decreased risk of neuropraxia. in an effort to achieve a balance between oncological excision and functional preservation, prostate surgery is evolving to incorporate intraoperative real-time evaluation of extracapsular extension. recently, a micro-ultrasound operating at 29 mhz has been introduced. it provides a resolution down to 70 μ to assess the glandular pattern and cellular density of the prostatic tissue. given the experience in more than a thousand cases with this technology, and the growing literature showing promising results in the detection and staging of prostate cancer; the researchers decided to implement this tool as guidance for hydrodissection of the layers of the lateral prostatic fascia. robotic-assisted laparoscopic prostatectomy and safe (saline assisted fascial engorgement) nerve preservation guided by microultrasound (mus) is a prospective randomized controlled trial designed to evaluate the impact of normal saline solution hydrodissection (hd) on erectile function outcomes after ralp. this innovative approach consists of a transrectal ultrasound-guided hd using a high-resolution microultrasound (mus) (exactvu micro-ultrasound, exact imaging, markham, canada). the technique will be applied to those patients who undergo grade 1, 2, or 3 ns approach taking into account the grading system proposed by tewari et al. the hypothesis is that the safe technique could minimize the risk of a traumatic neurovascular bundle dissection while assessing the prostatic capsule integrity with a high-resolution mus. the researchers also hypothesize that the use of safe along with ralp will optimize the post-surgery recovery of erectile function.


Eligibility criteria:
inclusion criteria: * age \> 18 years at the time of consent. * men who are potent (shim ≥ 17) and sexually active, who are planned to undergo a grade 1, 2, or 3 nerve-sparing approaches, as per the grading system during ralp. * ability to understand and the willingness to sign a written informed consent. exclusion criteria: * subjects who are candidates for salvage ralp * subjects on androgen deprivation therapy (adt) * subjects in whom pde5 inhibitors are contraindicated

Keywords: robotic-assisted laparoscopic prostatectomy (ralp) safe (saline assisted fascial engorgement)
glycemic load, weight loss and cardiovascular disease risk

Conditions: Overweight; Obesity

Summary: to investigate the hypothesis that reducing the glycemic load of the diet will improve changes in body composition and cardio-vascular risk factors. the study compares a conventional reduced-fat, high carbohydrate diet with 3 means of reducing glycemic load: changing the carbohydrates to low-gi choices, replacing some of the carbohydrate with protein, or combining both effects to produce the lowest glycemic load.

conventional low fat diets produce modest wegiht loss at best and the results are not well maintained. more recently there has been interest in low glycemic index and high protien diets wiht some evidence that these produce better fat loss and improvement in cardiovascular risk factors. this trial aims to evaluate these different approaches and compare the outcomes over 12 weeks. major outcomes are weigth loss, body composition change, blood lipids change, measures of glucose homeostasis, insulin resistance, leptin and crp.

Eligibility criteria:
inclusion criteria: * 18-40 years of age bmi \>=25 stable weight for 3 months non-vegetarian good understanding of english exclusion criteria: medications other than the contraceptive pill weight \>150kg (weight limit of dexa machine) vegetarian (diets included red meat) specific diets diabetes or impaired glucose tolerance pregnancy -

Keywords: overweight obesity glycemic index glycemic load high protein diet blood cholesterol
diagnostic value of sonazoid contrast-enhanced ultrasound in renal tumors

Conditions: Contrast Enhanced Ultrasound

Summary: the incidence and mortality of renal cell carcinoma are increasing year by year. contrast-enhanced ultrasound is helpful for early diagnosis and treatment to renal tumor, and is of great importance to distinguish benign from malignant and clinical stages

the morbidity of renal cell carcinoma is only lower to prostate cancer and bladder cancer in urinary tumor, and the mortality rate is up to 40%. at present, diagnostic techniques such as ultrasonography, ct examination and mri examination are widely used in clinical practice, which greatly improves the detection rate of asymptomatic renal cell carcinoma. compared with enhanced mri and enhanced ct, contrast-enhanced ultrasound (ceus) has outstanding advantages, including spatial, temporal and contrast resolution, continuous real-time visualization,. sonazoid, the second generation ultrasound contrast agent, is composed of microbubbles containing chemically stable and insoluble perfluorobutane (pfb) gas and phosphatidylserine sodium hard shell (diameter 2-3μm) wrapped by outer layer. these microbubbles can generate stable nonlinear oscillation in low-power sound field, and generate echo at the second harmonic frequency of transmitted pulse. sonazoid has the advantages of long-time development and good stability, which may improve the accuracy of distinguishing benign and malignant renal space-occupying lesions, especially small lesions. in addition, the characteristics of long-time development are also helpful to extract more imaging information to assist the clinical staging of renal tumors.

Eligibility criteria:
inclusion criteria: * (1) the subjects are able and willing to abide by the research procedure and sign the informed consent form; (2) the subjects who received cect or cemri examination of renal tumor before the treatment; (4) patients with no serious cardiovascular and cerebrovascular diseases; (5) patients who intend to undergo biopsy or lesion resection；(6) aged 18 -85;。 exclusion criteria: * (1) pregnant or lactating patients; (2) the subject has a history of allergy to eggs or egg products (i.e., general rash, dyspnea, swelling of mouth or throat, hypotension or shock, etc.); (3) it is known that the subject is allergic to perfluorobutane gas or any component of sonazoid; (4) patients who can't receive contrast mri or enhanced ct examination.

Keywords: kidney
vibrational therapy to improve gait and balance in parkinson's disease

Conditions: Parkinson Disease

Summary: the purpose of this research study is to determine optimum dose of vibration delivered by an experimental device called pdvibe2 required to treat freezing of gait in persons with parkinson's disease (pd). the pdvibe2 was developed by resonate forward, llc (rf). this pdvibe2 was designed to administer vibration therapy to the wearer to improve gait and balance in persons with pd while wearing the device.

participation will require up to 8 treatment sessions within 5 days (no more than 2 sessions in one day) plus an additional day for screening and another for follow-up (7 days total). all visits will occur at the virginia commonwealth university parkinson's movement and disorders center in richmond, va. participants will be asked to walk for a brief period of time while wearing the pdvibe2. the pdvibe2 will provide vibration therapy and study staff will measure the number of "freezes" before, during and after therapy. participants will be asked to provide feedback on the device, the therapy session and how they are feeling.

Eligibility criteria:
inclusion criteria: * age 21 years or older * pd diagnosed by a movement disorder specialist for 3 months or longer prior to recruitment * pd medication regimen is stable over the last 3 months with no changes * hoehn \& yahr stage 2 (n = 13) and h\&y stage 3 (n=13), * able to walk independently or with a simple assistive device (e.g., cane, walker) * observed by the research team to have pd related gait disturbance such as fog, shortened or irregular stride lengths, irregular step cadence, slowed speed while on their regular treatment regimen. exclusion criteria: * diagnosed with a known parkinson plus syndrome * were previously exposed to vibration treatment for gait and balance * presence of dementia (montreal cognitive assessment \< 21) * additional disorders (not related to pd)impairing gait, stance, balance or coordination (e.g. stroke, leg amputations, or multiple sclerosis) * history of implantable cardiac device or any other implanted electronic device except a deep brain stimulator (dbs) * use of braces/orthotics that assist with walking * are currently in physical therapy (pt) treatment for balance or gait * peripheral neuropathy by exam * any condition that, in the opinion of the pis, would compromise participant safety, data integrity, or data interpretation. * children under the age of 18 * prisoners * women who are pregnant or may become pregnant during the course of this study since the safety of this device for an unborn child is unknown.

Keywords: gait balance
effect of vitamin d on skeletal muscle function and qol in patients with chronic intestinal failure/insufficiency

Conditions: Intestinal Failure

Summary: eligible patients were randomized into two groups: vitamin d group and control group. control group: routine treatment only, no additional vitamin d intervention therapy. vitamin d group: in addition to the conventional treatment, additional intramuscular injection of vitamin d2 was given once every two weeks, each dose of 600,000 units, and the treatment lasted for 12 weeks. the primary and secondary outcomes will be collected.

eligible patients with chronic intestinal failure/insufficiency were randomly assigned to one of two groups, vitamin d group and control group. control group: routine treatment only, no additional vitamin d intervention therapy. vitamin d group: in addition to the conventional treatment, additional intramuscular injection of vitamin d2 was given once every two weeks, each dose of 600,000 units, and the treatment lasted for 12 weeks. the primary and secondary outcomes will be collected.

Eligibility criteria:
inclusion criteria: 1. informed consent was obtained from patients or their legal representatives for participation in this study 2. patients 18 years of age or older, under 70 years of age, chronic intestinal failure/insufficiency 3. serum 25(oh)d level \< 30.0 ng/ml 4. vital signs are stable exclusion criteria: 1. those who did not meet the inclusion criteria, or who were deemed unfit by their physician to participate in this study 2. primary hypothyroidism or parathyroidism 3. patients suffering from allergic diseases, are allergic, have a history of drug sensitivity similar to the structure of the study drug 4. patients with primary diabetes 5. patients with mental illness, inability to cooperate or consciousness disorders 6. patients with contraindications of experimental drugs 7. patients with a suspected or confirmed history of substance abuse 8. immune deficiency, use of immunosuppressants and hormones 9. pregnant and lactating women 10. have taken any vitamin d supplements in the last 6 months 11. have taken any medication in the last 6 months that affects vitamin d metabolism (e.g., phenytoin, phenobarbital, rifampicin) 12. patients who participated in a drug trial (including the drug in the trial) within 3 months before the trial 13. sponsors or investigators directly involved in the trial or their family members 14. the researcher believes that there is any reason not to be accepted

Keywords: vitamin d quality of life muscle function chronic intestinal failure
medication development for protracted abstinence in alcoholism: cort118335 versus placebo

Conditions: Alcohol Use Disorder

Summary: the hypotheses under test are that subjects with alcohol use disorder (aud) of moderate or greater severity treated with cort118335 will report decreased craving for alcohol following alcohol exposure in the laboratory and report significantly less drinking under naturalistic conditions, than those treated with placebo.


Eligibility criteria:
inclusion criteria: * male or female volunteers, 18-75 years of age. * meets dsm-5 criteria for current alcohol use disorder of moderate or greater severity (aud-ms). * subjects will not be seeking treatment because the medication studies are not treatment trials, and to avoid exposing treatment-seekers to alcohol cues. * subjects must be abstinent a minimum of 3 days (but not more than 7 days) prior to the human lab session. * in acceptable health in the judgment of the study physician, based on interview, medical history, physical exam, ecg, routine urine and blood chemistry. * subjects with a history of depression, who have been on a stable dose of anti-depressant medication for at least 3 months, and do not meet current dsm-5 criteria for depression or anxiety. * all subjects must agree to use double barrier birth control for the study duration and one month thereafter i.e., males must use condoms and females must use spermicide and/or a non hormonal barrier method, and their opposite sex partner must likewise use an effective non hormonal form of contraception. * able to provide informed consent and understand questionnaires and study procedures in english. * willing to comply with the provisions of the protocol and take daily oral medication exclusion criteria: * medical conditions that could be aggravated by glucocorticoid and/or mineralocorticoid antagonism. * clinically significant findings on physical exam, ecg, urine or blood tests that may increase risk. * cyp2c19 inhibitors * substrates metabolized primarily by cyp3a, cyp2c9, and cyp2c8 with narrow therapeutic index * bcrp and ugt1a1 substrates * meets dsm-5 criteria for a current major psychiatric disorder, including mood, anxiety or substance use disorders, other than alcohol, nicotine, or mild cannabis use disorders. * pregnant or lactating. * treatment within the month prior to screening with (1) an investigational drug, (2) drugs which may negatively interact with study medications, or (3) drugs that may influence study outcomes (e.g., disulfiram \[antabuse\], naltrexone \[revia\], acamprosate \[campral\], or anticonvulsants. * chronic systemic steroid use * using drugs that are strong inhibitors and inducers of cyp2c9. * no fixed domicile and/or no availability by home or mobile telephone.

Keywords: alcohol-related disorders
comparative effects of play based therapy and functional communication training in speech-language delayed children

Conditions: Speech, Language Developmental Delay From Hearing Loss

Summary: the purpose of this study is to compare the play based therapy and functional communication training in speech-language delayed children 2-6 years old. this study will highlight the most effective intervention or therapy for speech \& language delayed children. the randomized clinical trial study will be conducted in clinic, sehat medical complex, with children who will have the diagnosis of speech and language delay. these individual will be diagnose by a speech therapist (more than 2 years experience in the field) with portage guide to early education . a group of children will be given play based therapy and the other group of children will be given functional communication training. participants' assessments of sld will be made using the portage guide to early education. it will take three months of sessions 5 days in a week, lasting 20 to 30 minutes. the progress of both therapies will be seen and assessed through structured questionnaire that which technique is more effective. the individual will be assess through speech questionnaire on base line and after 3 months session program.

speech is the verbal production of language, whereas language is the conceptual processing of communication. language includes receptive language (understanding) and expressive language (the ability to convey information, feelings, thoughts, and ideas). language is commonly thought of in its spoken form, but may also include a visual form, such as american sign language. speech and language delay in children is associated with increased difficulty with reading, writing, attention, and socialization. in children not meeting the expected milestones for speech and language, a comprehensive developmental evaluation is essential, because atypical language development can be a secondary characteristic of other physical and developmental problems that may first manifest as language problems.

Eligibility criteria:
inclusion criteria: * participants with comorbidity of behavioral disorder, autism \& adhd exclusion criteria: * patient with comorbidity of syndromes ( downs syndrome, treacher collin syndrome, hunter syndrome , williams syndrome, kabuki syndrome etc )

Keywords: play based therapy functional communication training
intravenous lidocaine and postoperative pain management

Conditions: Postoperative Pain Management

Summary: this study was to evaluate the effect of intraoperative intravenous lidocaine on postoperative pain management after laparoscopic cholecystectomy. half of patients will receive intravenous lidocaine during procedure, the rest half of patients will receive regular anesthesia care and placebo treatment.

postoperative pain and ileus are primary reasons for delayed patient recovery and longer hospital stays after abdominal surgery. opioids have been widely used to treat pain in this patient population. however, opioid administration can exacerbate postoperative ileus and further delay patient recovery. multimodal approaches and adjunctive therapies are therefore recommended for pain control after abdominal surgery to reduce opioid consumption and opioid-related adverse effects. studies have reported that systemically administered lidocaine has analgesic, anti-inflammatory, and anti-hyperalgesic effects. several clinical trials have been published that evaluated systemically administered lidocaine for postoperative pain management and recovery after surgery. however, the evidence for beneficial effects of systemic lidocaine for postoperative recovery remains controversial. therefore, the investigators performed this study to evaluate the efficacy of systemic administration of lidocaine for postoperative analgesia and gastrointestinal recovery after laparoscopic cholecystectomy. the investigators primary hypothesis is that systemic lidocaine administration reduces pain intensity following surgery.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologist (asa) status i-ii adult patients undergoing elective laparoscopic cholecystectomy. exclusion criteria: * open surgery; * patients allergic to lidocaine or other local anesthetics; * drug abuser.

Keywords: intravenous lidocaine postoperative pain management
dementia in long term care facilities: telemedicine for the management of neuropsychiatric symptoms

Conditions: Dementia

Summary: telemedicine may facilitate adequate treatment of neuropsychiatric symptoms (nps) by identifying underlying causes and tailoring a treatment plan (pharmacological or non-pharmacologic treatments including provision of staff education and support, training in problem solving, and targeted therapy directed at the underlying causes for specific behaviors).

during a 6-months period, patients will be included in both arms, whenever they present a disruptive nps that requires a specialist consultation based on the long-term care facility (ltcf) staff judgment. in the intervention group, a telemedicine (tm) consultation between the ltcf staff (medical and nurse staff) and the memory center from the university hospital, will occur at inclusion (t0). then, a second tm consultation will occur at 1 month (t1). in the control group management of nps will be done as usual care. in both groups, patients' parameters such as non-programmed hospitalizations and/or consultations due to disruptive nps, psychotropic drugs use, and health costs, will be evaluated at inclusion, 1 month and at 2 months. acceptability of the tm among the ltcf staff will be assessed during the study in the intervention group. the two university hospitals are composed of a group of institutions for elderly people located near toulouse and limoges.

Eligibility criteria:
inclusion criteria: * patient aged 65 or more, with a dementia diagnosed by a specialist or the general practitioner; * patient presenting with a disruptive nps as defined in french haute autorité de santé (has) recommendations (2009), that requires a specialist consultation based on the ltcf staff judgment; * informed and written consent by the patient or the legal representative or the reliable person when appropriate; * general practitioner agreement. exclusion criteria: * patient's life expectancy less than 6 months; * non agreement of study participation of patients or legal representative or the reliable person when appropriate.

Keywords: neuropsychiatric symptoms dementia telemedicine long-term care facilities